BrainsWay Receives FDA Clearance of Next Generation Stimulator, Enhancing Its Current Deep Transcranial Magnetic Stimulation (Deep TMS) System for Treatment of Major Depressive Disorder

The company will now have the most advanced stimulator on the market, with enhancedfeatures that increase the ease of use for physicians and integrate a patient management system

BrainsWay will be demonstrating the new stimulator at their booths at the AmericanPsychiatric Association and Clinical Transcranial Magnetic Stimulation Society AnnualMeetings taking place in NYC May 6-13, 2018

HACKENSACK, N.J., May 06, 2018 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (TASE:BRIN), the parent company of BrainsWay USA, Inc., and a global leader in the advanced non-invasive treatment of brain disorders, announces today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new stimulator to be integrated into BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) System for the treatment of Major Depressive Disorder (MDD).

BrainsWay’s next-generation stimulator enhances the complete Deep TMS system and streamlines treatment for physicians and their patients. It is the most advanced stimulator in its class and custom-designed with the Company’s proprietary H-Coil helmet for the treatment of MDD. BrainsWay’s Deep TMS proprietary H-Coil technology reaches deeper and larger surface areas of the brain than standard TMS treatments.

The new stimulator provides enhanced features focused on increasing the ease of use for the physician, integrating enhanced energy utilization, a patient management system with the built-in depression treatment protocol and a user-friendly tool for accurate, rapid motor threshold detection. These features will decrease set up time and increase office efficiencies.

“BrainsWay’s new stimulator represents a very important product advancement that solidifies the company’s leading innovative position within the US market. Furthermore, it sets the foundation for BrainsWay to become a fully integrated company that develops, produces and commercializes our innovative, non-invasive medical systems for the treatment of brain disorders globally,” said Yaacov Michlin, CEO of BrainsWay.

About Major Depressive Disorder (MDD) Overall, there are more than 15 million people in the U.S. who suffer from depression, making MDD a remarkably common disease. Within the total population of individuals with MDD, there is a subpopulation associated with even greater individual costs related to the disease. This subgroup of MDD patients experience treatment-resistant depression (TRD), which is defined as depression that does not respond to treatment with antidepressant medications. Roughly 29% to 46% of MDD patients fail to respond adequately to antidepressant medications, and only approximately 30% of patients achieve remission from first-line pharmacological treatment. Patients who are more resistant to treatment (fail to respond to a greater number of medications) tend to experience lower rates of remission. MDD is often recurrent, and at least 50% of those who experience a single episode and 80% of those who experience two episodes will have another in their lifetime. MDD is considered to be the psychiatric disorder with the greatest economic burden in the U.S., with costs totaling $210 billion annually, and antidepressant expenditure totaling roughly $15 billion annually.

About BrainsWay BrainsWay is engaged in the research, development and marketing of a medical system for non-invasive treatment of common brain disorders. The medical system developed and manufactured by the company is based on a unique and breakthrough technology called Deep TMS, which can reach the depth of the brain and produce nerve stimulation or suppression. About 90% of US depression patients currently have coverage for BrainsWay treatment. The company's systems, which are sold worldwide, have received FDA clearance for Major Depressive Disorder (MDD), and CE clearance for MDD and other indications.

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